We are seeking a highly experienced Validation Subject Matter Expert (SME) to support validation and technical transfer activities related to new pharmaceutical product launches. This role focuses on reviewing, auditing, and supporting the completion of cleaning validation and related documentation in preparation for a regulatory inspection.
The ideal candidate will bring deep expertise in cleaning validation, technical transfer, and regulatory compliance, with hands-on experience in drug substance operations.
Responsibilities:
- Conduct audits of cleaning validation documentation (protocols, deviations, change controls, reports) to ensure compliance with regulatory expectations and internal standards.
- Identify and flag any gaps, discrepancies, or deviations from industry standards and provide clear remediation recommendations.
- Assess and challenge justifications for unexpected events, changes to validation strategies, and cleaning validation campaign results.
- Verify alignment between technical reports and regulatory filings/marketing authorization documentation.
- Prepare and deliver weekly reports summarizing findings, recommendations, and status updates.
- Generate high-quality validation summary reports and presentation decks for multiple products.
- Collaborate with cross-functional teams including QA, Validation, Regulatory, and Operations.
Qualifications:
- Bachelor’s degree (or higher) in Engineering, Life Sciences, or related field.
- Minimum 7 years of experience in validation within the pharmaceutical industry.
- Proven expertise in cleaning validation, including protocol development, execution, and review.
- Prior experience with technical transfer of new products in drug substance manufacturing.
- Strong knowledge of FDA regulations, ICH guidelines, and industry best practices.
- Exceptional attention to detail and analytical thinking.
- Excellent technical writing and communication skills.
- Ability to work independently and manage priorities in a deadline-driven environment.
Job Type:
- Full-time
Education:
- Bachelor’s (Required)
Experience:
- Involvement in validation activities supporting regulatory inspections or pre-approval audits.
- Familiarity with reviewing validation documentation against filing/marketing authorization materials.
- Experience in compiling and presenting data to senior leadership and regulatory stakeholders.
Language:
- Spanish (Required)
- English (Required)
Ability to Commute:
- Juncos, PR 00777 (Required)
Ability to Relocate:
- Juncos, PR 00777: Relocate before starting work (Required)
Work Location:
- In person